Palomid 529 in Patients With Neovascular Age-Related Macular Degeneration

• STUDY EYE INCLUSION CRITERIA:

  1. Participant must have active neovascular AMD in at least one eye (the study eye) as defined by the following criteria:

     • CNV in the setting of AMD resulting in fluid or blood within the macula as determined by clinical examination, OCT or FA.
     • The study eye has not responded to conventional anti-VEGF treatment (defined as the eye that has any persistent intraretinal cyst with a greatest linear dimension of at least 100 microns and/or subretinal fluid pocket with a height of at least 100 microns and/or the presence of any foveal fluid after four serial anti-VEGF intravitreal injections). The fluid state will be determined two weeks (plus or minus two days) after the last injection.
  2. Participant must have reasonably clear media and some fixation to allow for good quality OCT and fundus photography.
  3. Participant must have visual acuity of 20 over 40 or worse in the study eye. Participants who meet all other eligibility criteria and have visual acuity between 20 over 32 and 20 over 40 may be enrolled if their disease is considered vision-threatening as determined by the investigator (i.e., they have persistent fluid under the fovea and are not responding to standard-of-care anti-VEGF treatment).

INCLUSION CRITERIA:

• Participant must be 18 years of age or older.
• Participant must understand and sign the protocol s informed consent document.
• Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be willing to undergo pregnancy tests throughout the study.
• Women of childbearing potential must agree to use reliable methods of contraception during the study period and for three months following the last injection. Acceptable methods of contraception include hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation or partner with vasectomy).

EXCLUSION CRITERIA:

• Participant is actively receiving another investigational study therapy. Participation in NIH protocol 08-EI-0103, High Speed Indocyanine Green Angiography Findings in Induction Regimen of Intravitreal Ranibizumab Injection for Neovascular Age-Related Macular Degeneration is allowed, if s/he has been enrolled for at least one year, as this is an imaging study providing standard-of-care ranibizumab.
• Participant is unable to comply with study procedures or follow-up visits.
• Participant has evidence of ocular disease other than neovascular AMD in the study eye that may confound the outcome of the study (i.e., diabetic macular edema, myopic choroidal neovascularization or uveitic macular edema).
• Participant has evidence of retinal pigment epithelial detachment (unless subretinal or intraretinal fluid is present)in the study eye.
• Participant received an anti-VEGF injection in the study eye within 12 days prior to enrollment.
• Participant received or has been receiving intraocular steroids in the study eye within four months prior to enrollment.
• Participant received or has been receiving immunosuppressive treatments (i.e., biologic or systemic steroids) within two months prior to enrollment. If the participant was on any systemic immunosuppressive treatment for at least two months prior to enrollment and meets the enrollment criteria of residual fluid after four serial anti-VEGF injections, then s/he is eligible to participate in the study as long as s/he will continue this specific systemic drug regimen for the entire study period.
• Participant is allergic to fluorescein dye or indocyanine green dye.
• Participant is allergic to shellfish or iodine.